Functional & Integrative Autoimmune Virologist / Clinical Research Professional with expertise in investigational and approved biologics, IVD medical devices, and adaptogenic dietary supplements. Skilled in managing multi-phase trials with strict adherence to regulatory compliance, contributing to protocol development and execution. Proven success in site management, facilitating large-scale, multi-center recruitment for international clinical trials, and leveraging comprehensive regulatory knowledge to ensure successful research execution. Strong organizational abilities across all aspects of clinical research and manufacturing, from patient recruitment to data collection and adverse event reporting. A collaborative team player adept at fostering communication to drive advancements in treatments and therapies.Core Competencies:Clinical Study Management: Oversaw and monitored clinical studies with a focus on regulatory compliance, commercial potential, and protocol adherence. Conducted site visits at all stages with meticulous documentation.Site Personnel Training: Led in-depth training sessions for site personnel, sharing therapeutic knowledge, protocol guidelines, documentation standards, and guidance on completing case report forms accurately.Supply Management: Efficiently managed investigational supplies, ensuring precise preparation, shipping, tracking, and retrieval, with thorough record-keeping throughout the process.Regulatory Compliance: Ensured strict adherence to protocols and regulatory guidelines, with diligent oversight of investigational product and lab sample storage, shipment, and reconciliation.Interdisciplinary Collaboration & Patient Support: Collaborated with medical professionals to maintain accurate records, coordinate appointments, treatments, and ensure clear communication among healthcare teams. Demonstrated compassion, resilience, and provided support to patients and their families throughout the clinical process.